‘Engadget’ Names Olive Union’s Smart Ear as ‘Best Wearable’
Olive Union announced that Engadget awarded its Smart Ear as the “Best Wearable” in the...
Category: Personal Sound Amplification
Personal Sound Amplification
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Personal Sound Amplification
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Intricon Enters into Partnership with Puretone; Sells PC Werth to Warner Tech-care
IntriCon has announced a distribution agreement with Puretone Ltd, a UK-based hearing health company with operations in more than 75 countries and access to Britain's NHS, and the sale of IntriCon's London-based subsidiary, PC Werth, to Warner Tech-care Products.
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FDA Issues Letter to “OTC Hearing Aid” Manufacturers
A letter by the FDA's William Maisel cautions that hearing devices cannot use “OTC hearing aids” in their marketing since the FDA definition of this hearing aid class—which would probably include severity of loss and other important safety, quality, and labeling requirements—has not yet been established.
Evaluating Select Personal Sound Amplifiers and a Consumer-Decision Model for OTC Amplification
OTC hearing devices are coming, but how should they function and for whom should they be recommended? Drs Ron Leavitt, Ruth Bentler, and Carol Flexer present six case studies showing that people with true moderate hearing loss may not be well served by what has been characterized as a “consumer-decides” model of care.
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iHEAR Medical Announces OTC Product Launch in Stores; Appoints John Luna CEO
iHEAR will launch the TReO, what the company says is the “first prescription-quality hearing amplifier for OTC markets,” and the iHearTest kit, a FDA-cleared home hearing screener, in 500 drugstores in June 2018.
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InnerScope Hearing Technologies Announces New E-Commerce Store
InnerScope continues to expand infrastructure and growth capabilities within its new e-commerce platform, according to the company.
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InterScope Hearing Technologies and Blue-Gear Enter Into Agreement
The agreement expands and broadens InnerScope Hearing Technologies’ presence in the new emerging PSAP’s and hearables markets.
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Staff Standpoint: OTC Debate Moves on to FDA, FTC…and States?
The debate now moves from “if” an OTC class of hearing devices should exist to “what” that OTC class will look like.
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Some PSAPs Show Improvements in Hearing Similar to Hearing Aids, Says JAMA Study
Three of the PSAPs were associated with improvements in speech understanding that were similar to results obtained with the hearing aid; one demonstrated little improvement; and speech understanding was worse with one PSAP.
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Consumer Technology Association Releases New Logo for OTC Hearing Devices
The new logo and standard will help consumers in the future, distinguish high-quality hearing enhancement devices for mild to moderate hearing loss from what the CTA says are “ineffective” personal amplifiers commonly found today.
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Some Turbulent Seas Ahead…
This month’s cover is meant to depict the turmoil that our industry finds itself in, as disruptive technology threatens to change some long-standing rules about hearing aid distribution and over-the-counter (OTC) hearing aids move a step closer to reality.
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FTC to Host April 18 Workshop on Hearing Care
The “Now Hear This” workshop will start at 9:00 am, with Acting Chairman Ohlhausen delivering opening remarks. The event will examine hearing care issues, especially as they relate to competition, innovation, and consumer protection and will be webcast live from the FTC’s web page.
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Elite 2017 Business Summit Elevates Independents in Era of Disruptive Change
This year’s Summit theme was “Elevate Your Independence,” focusing on how independent hearing care professionals can succeed in an era of disruptive technology, distribution, and what may ultimately be a new regulatory environment. Included in the Summit’s General Session was a historical perspective on the current over-the-counter device proposals, as well as a review of a recent pilot study that supports professionally dispensed hearing aids over OTC.
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HIA Recommends OTC Hearing Devices Be Restricted to Mild Losses; Retain Consumer Safety and Efficacy Assurances
The Hearing Industries Association has recommended that, if the FDA creates a new over-the-counter (OTC) category for hearing devices, these products be confined to mild hearing losses and comply with the same safety and efficacy standards required for air-conduction hearing aids. Further, if the OTC category is established, HIA recommends that FDA review and finalize its guidance for PSAPs so these devices cannot be marketed to address hearing loss.
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Gaming Technology for Customized Aural Rehabilitation and Hearing Healthcare
Nancy Tye-Murray, PhD, explains how gaming technology—and game-based learning—may play an important role in our future. Dr Tye-Murray describes the clEAR (customized learning: Exercises for Aural Rehabilitation) program and how it works.
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Philip Lyons Joins Earlens as Senior VP of Sales and Professional Education
Earlens has hired long-time Starkey executive Phil Lyons as its senior VP of sales and professional education. The company plans to launch its unique Light-Driven Hearing Aid in the second quarter of this year.
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Reopening of FDA Comment Period on PSAP Draft Guidance Announced
The FDA has reopened the comment period regarding its Draft Guidance document. A revised Guidance should further clarify the regulatory distinctions between hearing aids and PSAPs. An FDA workshop on GMPs is scheduled for April 21 at FDA headquarters.
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ADA Lends Qualified Support for PCAST Recommendations
In giving qualified support to the PCAST recommendations, ADA is the first among the hearing care professional organizations to publicly endorse, at least in principle, the PCAST’s report to the president. However, ADA listed a number of important qualifications emphasizing the importance of the audiologists’ role in hearing evaluation and diagnostics, dispensing, and aural rehabilitation, as well as some necessary standards for PSAPs, entry-level devices, and hearables.
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